MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. CLARIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMA1QQ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Syncope (1610); Atrial Fibrillation (1729); Death (1802); Cardiogenic Shock (2262); Pericardial Effusion (3271)

Event Date 01/03/2020

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient contacted the cardiology office complaint of large bloody drainage from the pocket two and half weeks post implant.It was noted the patient was able to manage it conservatively at home.The patient presented to the office 5 days later stating the wound looked worse.It was discovered the wound had dehisced.The patient was treated with antibiotics and the cardiac resynchronization therapy defibrillator (crt-d) system was explanted.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that wound tissue cultures were taken and tested for gram positive cocci.Additional antibiotic treatment was given to the patient.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that on the day of the implant procedure, an effusion was observed and the patient had a drain placed; an echocardiogram was performed later that day and the effusion has resolved.Approximately three weeks later, the patient underwent explant of the system due to infection; following removal of the system, the patient had an echocardiogram performed, which showed a small to moderate pericardial effusion.The patient was discharged with a wound vacuum and a wearable cardioverter defibrillator.The patient was admitted two weeks later due to atrial fibrillation (af), which they had no previous history of.A transesophageal echocardiogram (tee) showed a small pericardial effusion and the patient was cardioverted upon admission.The patient then presented approximately eleven weeks later due to a syncopal episode and diagnosed with effusion.A pericardial window was placed the following day.The patient required long-term ventilator and pressor support.The patient was weaned off the ventilator, however, the pressor could not be weaned.The patient declined and was discontinued home to hospice care, where they later passed away due to cardiogenic shock and renal failure.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLARIA MRI QUAD CRT-D SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9654370
• MDR Text Key: 177209365
• Report Number: 3004209178-2020-02313
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169720633
• UDI-Public: 00643169720633
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2021
• Device Model Number: DTMA1QQ
• Device Catalogue Number: DTMA1QQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5076-52 LEAD, 6935M62 LEAD, 429888 LEAD
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 70